MAUDE Adverse Event Report: MIDMARK CORP PROGENY PREVA; UNIT, X-RAY, EXTRAORAL WITH TIMER, PRODUCT CODE: EHD

Model Number PREVA

Device Problem Installation-Related Problem (2965)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/17/2009

Event Type  malfunction  

Event Description

It was reported to midmark that an x-ray unit (preva intraoral dental x-ray system, serial no.(b)(4)) separated from its wall mount in a hospital.No injuries were reported.Complaint investigation determined that the root cause was improper installation error on the part of the distributor.Unit was installed into a brick wall, which is not a recommended condition per manufacturer installation instructions and is not covered by hardware provided in the installation kit.This mdr is being submitted as part of retrospective complaint review conducted at midmark corporation ((b)(4)).Midmark (formerly progeny) began filing mdrs for x-ray units separating from their wall mounts in april 2009 (refer to mdr 1423380-2009-00006).All subsequent incidents involving units fully separating from the wall mount have been submitted to (b)(4) as mdrs.However, as part of retrospective complaint review, midmark has identified this unreported incident that occurred prior to april 2009 and has decided to report this incident for consistency.

• Brand Name: PROGENY PREVA
• Type of Device: UNIT, X-RAY, EXTRAORAL WITH TIMER, PRODUCT CODE: EHD
• Manufacturer (Section D): MIDMARK CORP; 675 heathrow drive; lincolnshire IL 60069
• Manufacturer Contact: nataliya khutorna ; 675 heathrow drive; lincolnshire, IL 60069 ; 8474159760
• MDR Report Key: 4546595
• MDR Text Key: 5517630
• Report Number: 1423380-2015-00003
• Device Sequence Number: 1
• Product Code: EHD
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K043092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/10/2009

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: PREVA
• Device Catalogue Number: PE7016
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/10/2009
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1